None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate the impact of androgen deprivation therapy (ADT) on cognitive function in men with prostate cancer. Who is it for? You may be eligible to enroll in this study if you are aged 18 or over and have been diagnosed with prostate cancer for which you have received no ADT previously. You must either be scheduled to begin ADT in the next month, or have no ADT planned. Study details All participants in this study will complete a screening questionnaire and then if eligible, an assessment session at enrolment and again 9 months later. Each assessment session is expected to last 45-80 minutes and will involve computer-based testing, pen and paper tasks, plus a number of paper questionnaires. It is hoped that this study will improve understanding of the cognitive effects of ADT in men with prostate cancer.
Interventions
Cognitive function tests
Computer based task
The Jansari assessment of Executive Functions, JEF (Copyright), is a novel, computer based virtual reality program.
In the assessment, a participant is invited to navigate around a Virtual Reality(VR) environment on a computer to complete a set of 10 listed tasks and a further 2 tasks that require creative thinking. The scenes are set in a typical office and meeting room. Participants are guided by a research team member with clear instructions given
Cognitive function tests Computer based task The Jansari assessment of Executive Functions, JEF (Copyright), is a novel, computer based virtual reality program. In the assessment, a participant is invited to navigate around a Virtual Reality(VR) environment on a computer to complete a set of 10 listed tasks and a further 2 tasks that require creative thinking. The scenes are set in a typical office and meeting room. Participants are guided by a research team member with clear instructions given for the assessment. No prior computer knowledge or use is required. The assessment takes on average 40 minutes to complete. Paper based tasks Four standardised measures of executive functions have been chosen based on recommendations by the International Cognition and Cancer Task Force (Wefel et al, 2011) and previous studies in this area. They assess the domains of different executive functions that can be evaluated against standardised norms. The tests comprise of the following: *Hopkins Verbal Learning Test – Revised (HVLT-R): 5-10 minutes with a 25 minute delay HVLT-R measures verbal memory. Participants are presented with 12 words over 3 immediate learning trials and 1 delayed recall trial followed by a recognition list task. *Trail Making Test (TMT) A: 1-2 minutes TMT A measures sustained attention and working memory. It requires a participant to connect numbered circles consecutively. *Trail Making Test (TMT ) B: 1-3 minutes TMT B measures an executive function - cognitive flexibility. Participants are asked to connect alternating numbers and letters in sequence. *Controlled Oral Word Association test (COWA): 3-5 minutes COWA is a measure of speeded lexical fluency using letters that correspond to specified word frequencies in the English language. Participants’ estimation of pre-morbid intelligence levels will be assessed by the following standardised test National Adult Reading Test (NART) The following Patient Reported Outcome (PRO) questionnaires will be used in this study to review impact of cognitive function on QoL: 1. EORTC QLQ-C30 2. EORTC PR-25 3. Hospital Anxiety and Depression Scale (HADS) 4. Fatigue Symptom Inventory (FSI) 5. Cognitive Failure Questionnaire (CFQ) 6. Cognitive Failure Questionnaire-for-others (CFQ-O) Who will deliver the intervention Assessments will be conducted by the researchers (trained to perform assessments) The mode of delivery Face to face individual assessments The number of times the intervention will be delivered and over what period of time Two time points-baseline and at 9 months. Duration of assessments 45mins to 80minutes Location Cancer care centre clinic
Sponsors
Nepean and Blue Mountains Local Health District
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
*Gender eligible for study: male *Prostate cancer diagnosis *MMSE > 24 *ECOG status between 0 – 1 *Speak and read English ADT group * Planned to commence ADT within 1 month nADT group * No prior or current ADT
Exclusion criteria
Participants are not eligible to participate on the following basis: *Commenced on ADT *Prior ADT *Previous or current chemotherapy treatment *Previous or current severe psychiatric history as defined by - A diagnosed mental illness involving psychosis - Hospitalisation for mental health difficulties *Current diagnosis of major depressive episode or an anxiety disorder *Previous or current neurological difficulties e.g. Seizures or stroke *Previous or current significant heart disease e.g. Myocardial infarction, Congestive Cardiac Failure *History of brain cancer *Patients with a past history of cancer in the 5 years before registration except for the following: Patients with squamous or basal cell carcinoma of the skin that has been effectively treated. *Life expectancy less than 1 year *Prior orchidectomy *Participation in other projects involving cognitive testing.
Outcome results
None listed